(WHS-P62) The Effects of a Copper-Iodine Complex Solution on the Reduction of Biofilms Grown on Implant Materials and In Vivo Porcine Wounds
Friday, May 17, 2024
7:30 AM – 5:00 PM East Coast USA Time
Introduction Copper-Iodine Complex Solution (CICS) is an FDA 510(k) cleared medical device as a wound irrigation system. This unique complex has the capacity to neutralize a broad number of pathogens such as bacteria, viruses, yeast, and fungi without evoking bacterial resistance. Free Iodine (I2) is a recognized powerful and broad-spectrum antimicrobial with no known resistance by exhibiting multi-mechanisms of action, highlighting: (i) penetration into the cell wall of the microorganism, causing blocking of the hydrogen bonds which results in damage to the phospholipid cell membrane, (ii) and damage and denaturing of the essential proteins, nucleotides and fatty acids by binding to thiol and amine groups, leading to rapid cell death. Free iodine acts as a preservative agent that helps to remove contamination within the CICS for effective wound cleaning. CICS has been proven to be non-cytotoxic, non-pyrogenic, non-irritating, and non-sensitizing to dermal tissue. The purpose of this study is to quantitatively evaluate the effect of CICS on biofilm in a porcine model and commonly used implant material substrates (silicone and titanium alloy). Materials and Methods Two implant materials were used in this study to grow biofilms, silicone, and titanium alloy substrates. Three independent time trials were conducted, 5h, 24h, and 72h. Data was analyzed with one-way Anova and Tukey post-hoc tests. p-value: <0.05. This In vitro biofilm test was conducted by the Center for Biofilm Engineering at Montana State University. Results 1. Efficacy of CICS against S. epidermidis mature biofilms on silicone substrate
Results: 1.7 log reduction at 30 min, 4.7 log reduction at 2 hours, 6.6 log reduction at 5 hours and 7.0 log reduction at 24h and 72h. No colonies observed at 24h and 72h. No statistical difference was observed between 5h, 24h and 72h kill rates. 2. Efficacy of Bioclynse against S. aureus mature biofilms on titanium alloy substrate
Results: 0.6 log reduction at 5 min, 1.8 log reduction at 0.5 hours, 4.7 log reduction at 2 hours and 7.5 log reduction at 24h. No colonies were observed at 24h. GLP in vivo study (porcine model) to assess the anti-biofilm and antimicrobial activity.
Results: CICS reduced total bacteria in the biofilm by 2.0 – 2.5 log CFUs compared to initial inoculation level. Conclusion Copper-Iodine Complex Solution has been shown to generate a significant log reduction in the growth of both Staph aureus and staph epidermidis biofilms grown on silicon and titanium implant materials. Biofilms were also reduced in a in vivo wound porcine model. Further studies are needed to show that this can help to prevent and to treat infected implants in humans.